ITMO public health
Last update : 07/15/2014 | Version : 1 | ID : 60184
| General | |
| Identification | |
| Detailed name | Prospective Cohort Study of Late Pulmonary Complications in Patients Who Received Allogeneic Hematopoietic Stem Cells Transplantation: Estimation of Incidence and Identification of Distinct Nosologic Entities |
| Sign or acronym | ALLOPULM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 01/11/2005 |
| General Aspects | |
| Medical area |
Cardiology Pneumology |
| Health determinants |
Climate Genetic Iatrogenic Intoxication Nutrition Pollution Social and psychosocial factors |
| Others (details) | Late pulmonary complications, allogeneic hematopoietic stem cells, assessment, incidence, nosology |
| Keywords | Hospitalised subjects, health system, clinical aspects, initial and progressive radiological and respiratory function, incidence |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bergeron-Lafaurie |
| Surname | Anne |
| Address | 75010 PARIS |
| Phone | +33 (0)1 42 49 41 66 |
| anne.bergeron-lafaurie@sls.aphp.fr | |
| Unit | APHP |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | APHP |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective |
| Database objective | |
| Main objective | General objective - To estimate the incidence of LONIPC: Late-onset non-infectious pulmonary complications - To characterise clinical and radiological aspects as well as initial and progressive respiratory function - To investigate factors leading to occurrence Secondary objective: - To estimate the incidence of LONIPC in HSCT (hematopoietic stem cell transplantation) on an unselected prospective cohort to allow a multi-centric prospective prognostic cohort study with satisfactory statistical power |
| Inclusion criteria | Patients who underwent a allogeneic blood stem cell transplantation and alive at 100 days |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Recruitment from bone marrow transplant patients at Hôpital Saint Louis de Paris |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 237 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Type of samples taken: FBC, platelets, liver function tests, immunophenotyping, IgE and Phadiatop, serum bank, serum electrolytes |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: entry from a paper questionnaire; Interviews: entry from a paper questionnaire; Clinical examinations: handwritten Biological analysis: handwritten |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 4 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16145172 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24732781 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23208317 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22672535 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22371177 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/19953024 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18029149 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17879919 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17666361 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17351647 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/16145172 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24732781 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/23208317 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22672535 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22371177 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/19953024 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18029149 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17879919 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17666361 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17351647 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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